CDSCO License for Dental amalgam

Comprehensive Guide to CDSCO Licensing for Dental Amalgam (Class B Medical Device)

Dental amalgam is a widely used dental restorative material primarily employed to fill tooth cavities. It is prepared by mixing liquid mercury (Hg) with an alloy of fine particles composed mainly of silver (Ag), tin (Sn), and copper (Cu). Classified as a Class B medical device under the CDSCO framework, dental amalgam manufacturing and import require strict adherence to regulatory pathways to ensure patient safety and compliance with Indian laws.

With over 25 years of experience and having supported 500+ companies in CDSCO licensing, we provide a detailed roadmap tailored specifically for dental amalgam manufacturers and importers entering the Indian market.

CDSCO Regulatory Framework for Dental Amalgam Devices

The Central Drugs Standard Control Organization (CDSCO) regulates all medical devices in India. Dental amalgam, notified under 29/Misc./03/2020-DC (140) Part-5 dated 10.10.2022, falls under the dental category and is classified as a Class B device. This classification dictates the licensing authority, documentation, fees, and timelines.

Manufacturing licenses for Class B devices are issued by the State Licensing Authority through the MD5 license process. Import licenses fall under the Central Licensing Authority with the MD15 licensing process.

Understanding this framework helps manufacturers and importers align their compliance strategies effectively.

Risk Classification and License Requirements for Dental Amalgam

As a Class B device, dental amalgam carries moderate risk. The regulatory requirements include:

• Manufacturing License: MD5 License (Application Form MD3) via State Authority
• Import License: MD15 License via Central Authority

This classification requires companies to obtain a test license (MD13), conduct product testing at government-approved labs, undergo audits by notified bodies, and meet comprehensive documentation standards.

Learn more about medical device classification here.

Manufacturing License Process for Dental Amalgam (MD5 License)

The manufacturing license process for dental amalgam under the MD5 license involves several key steps:

1. Apply for Test License (Form MD13): Initial step to legally manufacture the product for testing purposes; takes approximately 1.5 to 2 months.

2. Product Testing: Mandatory testing of dental amalgam samples at CDSCO-approved laboratories to verify safety and efficacy.

3. Document Preparation: Compilation of all regulatory documents including Device Master File, Plant Master File, Risk Management File, and QMS documents.

4. Apply for Manufacturing License (Form MD3): Submission of complete application on the CDSCO MD Online Portal.

5. Audit by Notified Body: A thorough audit of manufacturing facilities and quality systems performed by a notified body listed here.

6. Queries Resolution: Address any queries raised by CDSCO or the notified body.

7. Grant of License (Form MD5): Upon successful compliance, the manufacturing license is granted.

The entire process typically takes 3 to 4 months from test license application to final license issuance.

For detailed guidance, refer to our MD5 License Guide.

Manufacturing License Documents Required for Dental Amalgam

To ensure a smooth application process, prepare the following documents meticulously:

• Company Constitution (Incorporation Certificate, Partnership Deed, etc.)
• Proof of ownership or lease of manufacturing premises
• Details and qualifications of technical staff
• Fire NOC and Pollution Control Board NOC
• Device Master File: Detailed product specifications and design (Device Master File Guide)
• Plant Master File: Describes manufacturing facilities and equipment (Plant Master File Guide)
• Essential Principles Checklist ensuring compliance with safety standards
• Risk Management File documenting hazard identification and mitigation (Risk Management)
• Product test reports from government-approved labs (Testing Laboratories)
• Labels, Instructions for Use (IFU)
• Quality Management System (QMS) Documents (ISO 13485 certification recommended)

Ensure all documents are accurate, up-to-date, and reflect Indian regulatory requirements to prevent delays.

Import License Process for Dental Amalgam (MD15 License)

Importers of dental amalgam must obtain an MD15 license from the Central Licensing Authority, which involves:

1. Document Preparation: Gather manufacturing license, Free Sale Certificate, ISO 13485:2016 certificate, CE Certificate, Device Master File, Plant Master File, Wholesale License, and company constitution.

2. Application Submission: File the application on the CDSCO MD Online Portal using Form MD14.

3. Queries Resolution: Respond promptly to any queries from CDSCO.

4. License Grant: Upon satisfactory review, the import license is issued in Form MD15.

The process generally takes 5 to 6 months.

For detailed import license procedures, see our Import License Guide.

Import License Documents Required for Dental Amalgam

Key documents include:

• Valid Manufacturing License (MD5 or MD9)
• Free Sale Certificate from the country of origin
• ISO 13485:2016 certification
• CE Certificate for EU compliance
• Device Master File and Plant Master File
• Wholesale Drug License
• Company Constitution documents

Thorough preparation of these documents will significantly improve approval chances.

Timeline and Processing Duration

Planning your project timeline around these durations is critical to avoid market entry delays.

Government Fees and Costs

For dental amalgam (Class B device), the fees are as follows:

• MD5 License:

  • Application Fee: Rs 5,000
  • Per Product Fee: Rs 500

• MD15 Import License:

  • Per Site Fee: $2,000
  • Per Product Fee: $1,000

Additional costs include testing fees at approved laboratories and audit fees charged by notified bodies.

Budgeting accurately for these expenses will help avoid unexpected financial burdens.

Common Challenges and Solutions

Challenge 1: Delays in Test License Approval

• Solution: Submit a complete and error-free application for the MD13 test license. Engage experienced consultants to review submissions.

Challenge 2: Non-compliance during Audit

• Solution: Conduct pre-audit internal checks and ensure your QMS and manufacturing processes are fully compliant. Use the notified bodies list to select experienced auditors.

Challenge 3: Incomplete Documentation

• Solution: Prepare comprehensive Device and Plant Master Files, maintain updated risk management documentation, and ensure labels and IFUs meet CDSCO requirements.

Challenge 4: Lengthy Query Resolution

• Solution: Respond promptly and thoroughly to CDSCO queries with supporting documents and clarifications.

Expert Consultation and Support

Navigating CDSCO licensing for dental amalgam requires expertise to handle complex regulatory requirements, documentation, and audits efficiently. Our seasoned consultants have successfully guided over 500 companies through this process, reducing approval timelines and ensuring compliance.

We provide:

• End-to-end regulatory strategy
• Document preparation and review
• Liaison with CDSCO and notified bodies
• Support during audits and inspections

Get professional guidance to avoid costly mistakes and accelerate your market entry.

Getting Started with Your CDSCO License Application for Dental Amalgam

1. Assess Your Device Classification: Confirm dental amalgam is Class B as per the latest CDSCO notification.

2. Prepare Technical Documentation: Start compiling Device Master File, Plant Master File, Risk Management File, and QMS documentation.

3. Apply for Test License (MD13): Submit your test license application via the CDSCO MD Online Portal.

4. Perform Product Testing: Partner with CDSCO-approved labs for mandatory product testing.

5. Schedule Notified Body Audit: Select an appropriate notified body from the list of notified bodies and prepare for the audit.

6. Submit Manufacturing License Application (MD5): After successful test license and product testing, apply for the manufacturing license.

7. Engage Expert Consultants: Leverage our 25+ years of regulatory experience to streamline the entire process.

Starting early and following a structured approach is vital for timely and successful licensing of your dental amalgam device in India.

For more detailed insights and personalized support, connect with our regulatory team specializing in CDSCO licensing for dental and other medical devices.